Carotid Artery StenosisNCT04098523
Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study.
A study testing Duplex ultrasound in people with Carotid Artery Stenosis and Abdominal Aortic Aneurysm, run by Erik Debing at 1 site in Belgium.
Trial summary
Both abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS) are frequent clinical entities, with major morbidity and mortality. This project obtains robust data on the prevalence of AAA and CAS in the Brussels Capital Region. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Stenosis, Abdominal Aortic Aneurysm, Epidemiology
- What is being tested?
- Duplex ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,286 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Candidate is at least 60 years old.
- Candidate lives in Brussels capital region at the time of study participation.
- Candidate must sign and date the informed consent form prior to study participation.
Who cannot join
- 1. Candidate is suspected of being unable to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Both abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS) are frequent clinical entities, with major morbidity and mortality.
This project obtains robust data on the prevalence of AAA and CAS in the Brussels Capital Region. Using duplex ultrasound, a low invasive examination, we want to obtain information on a vast sample of men and women of the Brussels capital region, starting at the age of 60. With these data we can have a far better view on the Belgian situation of these two main vascular clinical entities. The data can provide insights on if, and how, Belgian public health policy can be improved concerning AAA and CAS.
Read the detailed description
A population-based screening study to determine the prevalence of carotid artery stenosis (CAS) and abdominal aortic aneurysms (AAA) in the Brussels Capital Region.
The study population is the 60+ inhabitants of the Brussels capital region; recruitment of 4680 subjects. Using duplex ultrasound, a low invasive examination, information is obtained on the abdominal aortic diameter and the degree of stenosis of the carotid bifurcation.
The objective is to determine not only the prevalence of, but also the risk factors associated with CAS and AAA among 60+ Brussels inhabitants. To collect these data, a questionnaire is made including demographic features, associated risk factors, but also previous treatment for AAA or CAS and the current medication of the subject.
Examination is done by one-time duplex ultrasound to perform a diameter measurement of the abdominal aorta and determine the degree of stenosis of the carotid arteries.
Data collection will be done in an electronic case report form, and statistical analysis will be done by a multi-variable logistic regression model.
- Being tested
- Duplex ultrasound
- Keywords
- Carotid Artery Stenosis, Abdominal Aortic Aneurysm, Epidemiology, Stenosis, Population screening
- Medical subject headings
- Carotid Stenosis, Aortic Aneurysm, Abdominal, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex ultrasoundDiagnostic test
A one-time carotis and abdominal aorta duplex ultrasound will be performed on-site by a skilled site staff to determine the prevalence of, and risk factors associated with, CAS and AAA. A diameter measurement will be performed of the abdominal aorta as well as a determination of the carotid arteries.
| Study group | Role | What they receive |
|---|---|---|
| Epidemiologic screening | Other | All subjects are screened by duplex ultrasound for abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS). A questionnaire is completed to obtain information on demographic information, risk factors as well as prior treatment for AAA or CAS and current medication. No treatment is given. Receives: Diagnostic Test: Duplex ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CAS and AAA among 60+ Brussels inhabitants.
Determine the prevalence using echo duplex screening.
Measured: Screening period of 2 years
Risk factors associated with CAS and AAA among 60+ Brussels inhabitants.
Determine the risk factors via a questionnaire:
- Smoking (ex - current - none)
- Hypertension (medical history - current)
- Coronary Artery Disease (history of angina pectoris or myocardial infarction)
- Diabetes Mellitus (history of diet or medically-treated diabetes - type I or II)
- History of Cerebro Vascular Disease (stroke or TIA)
- Family (parents/siblings) history (AAA, CVD, …)
- Hypercholesterolemia
- Body weight \& length (BMI)
- COPD
Measured: Screening period of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erik Debing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erik Debing, Universitair Ziekenhuis Brussel
- Investigators
- Erik Debing, Prof. Dr., Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098523
- Sponsor's protocol ID
- GALSKELA01
- Status last verified
- Feb 2024
- First submitted
- 4 Sep 2019
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study.
- ClinicalTrials.gov ID
- NCT04098523
- Acronym / sponsor ID
- GALSKELA01
- Keywords
- Carotid Artery Stenosis, Abdominal Aortic Aneurysm, Epidemiology, Stenosis, Population screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,286 participants (actual)
- Lead sponsor
- Erik DebingUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS) are frequent clinical entities, with major morbidity and mortality.
This project obtains robust data on the prevalence of AAA and CAS in the Brussels Capital Region. Using duplex ultrasound, a low invasive examination, we want to obtain information on a vast sample of men and women of the Brussels capital region, starting at the age of 60. With these data we can have a far better view on the Belgian situation of these two main vascular clinical entities. The data can provide insights on if, and how, Belgian public health policy can be improved concerning AAA and CAS.
Detailed description
A population-based screening study to determine the prevalence of carotid artery stenosis (CAS) and abdominal aortic aneurysms (AAA) in the Brussels Capital Region.
The study population is the 60+ inhabitants of the Brussels capital region; recruitment of 4680 subjects. Using duplex ultrasound, a low invasive examination, information is obtained on the abdominal aortic diameter and the degree of stenosis of the carotid bifurcation.
The objective is to determine not only the prevalence of, but also the risk factors associated with CAS and AAA among 60+ Brussels inhabitants. To collect these data, a questionnaire is made including demographic features, associated risk factors, but also previous treatment for AAA or CAS and the current medication of the subject.
Examination is done by one-time duplex ultrasound to perform a diameter measurement of the abdominal aorta and determine the degree of stenosis of the carotid arteries.
Data collection will be done in an electronic case report form, and statistical analysis will be done by a multi-variable logistic regression model.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidemiologic screening | Other | Diagnostic Test: Duplex ultrasoundAll subjects are screened by duplex ultrasound for abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS). A questionnaire is completed to obtain information on demographic information, risk factors as well as prior treatment for AAA or CAS and current medication. No treatment is given. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidate is at least 60 years old.
- Candidate lives in Brussels capital region at the time of study participation.
- Candidate must sign and date the informed consent form prior to study participation.
Key exclusion criteria (1 listed)
- 1. Candidate is suspected of being unable to comply with the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duplex ultrasoundA one-time carotis and abdominal aorta duplex ultrasound will be performed on-site by a skilled site staff to determine the prevalence of, and risk factors associated with, CAS and AAA. A diameter measurement will be performed of the abdominal aorta as well as a determination of the carotid arteries. | Diagnostic test | Epidemiologic screening |
Primary outcome
Prevalence of CAS and AAA among 60+ Brussels inhabitants.
Time frame: Screening period of 2 years
Determine the prevalence using echo duplex screening.
Risk factors associated with CAS and AAA among 60+ Brussels inhabitants.
Time frame: Screening period of 2 years
Determine the risk factors via a questionnaire: * Smoking (ex - current - none) * Hypertension (medical history - current) * Coronary Artery Disease (history of angina pectoris or myocardial infarction) * Diabetes Mellitus (history of diet or medically-treated diabetes - type I or II) * History of Cerebro Vascular Disease (stroke or TIA) * Family (parents/siblings) history (AAA, CVD, …) * Hypercholesterolemia * Body weight \& length (BMI) * COPD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Debing, Prof. Dr. principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duplex ultrasound in people with Carotid Artery Stenosis and Abdominal Aortic Aneurysm, run by Erik Debing at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CAS and AAA among 60+ Brussels inhabitants. (time frame: Screening period of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.